Back to resultsThe Safety, Acceptability and Efficacy of Alena
Primary Purpose
Social Anxiety, Social Anxiety Disorder, Social Anxiety Disorder (Social Phobia)
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy programme
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety focused on measuring RCT, CBT
Eligibility Criteria
Inclusion Criteria: female aged between 18 and 35 years old (inclusive) located in the UK fluent in English comfortable taking part in a study that included deception (due to the nature of the cognitive assessments) had an iPhone and daily access to an internet connection scored over 30 on the Social Phobia Inventory (SPIN; indicating at least moderate social anxiety). Exclusion Criteria: currently undergoing any mental health therapy changed the usual mental health medication or dosage within the past eight weeks scored eight or above on the Alcohol Use Disorders Identification Test for consumption (AUDIT-C; indicating higher risk of alcohol dependence) scored two or above on the adapted drug questions (indicating higher risk of drug dependence) had previously participated in scientific studies or user research undertaken by Alena
Sites / Locations
- Aya Technologies Limited
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive Behavioral Therapy program
Waitlist control
Arm Description
Access to the "Alena" CBT-based therapy programme for 4 weeks. Each of the four therapy modules gradually became available on a weekly basis until all four were available in the final intervention week. Participants were instructed to complete one module per week. Each therapy module consisted of psychoeducational content, guided psychological reflection and perspective-taking exercises, and, where appropriate, skills training exercises such as attention training, public speaking, and exposure experiments to be completed in real life.
Waitlist control. Participants in this arm were given access to the CBT content at the end of the 4-week trial period.
Outcomes
Primary Outcome Measures
Questionnaires assessing negative effects from using the app and adverse health events
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Questionnaires assessing negative effects from using the app and adverse health events
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Questionnaire assessing satisfaction, helpfulness and ease of use
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Questionnaire assessing satisfaction, helpfulness and ease of use
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Secondary Outcome Measures
Social phobia inventory (SPIN)
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.
Social phobia inventory (SPIN)
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.
Work and Social Adjustment Scale (WSAS)
The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities. Total score ranging from 0 to 40, with higher scores indicating higher impairment
Work and Social Adjustment Scale (WSAS)
The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities. Total score ranging from 0 to 40, with higher scores indicating higher impairment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05858294
Brief Title
The Safety, Acceptability and Efficacy of Alena
Official Title
The Safety, Acceptability and Efficacy of Alena, a Modularized CBT-based Mobile App Intervention for Social Anxiety: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
December 4, 2022 (Actual)
Study Completion Date
December 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aya Technologies Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The present study is a randomised controlled trial that seeks to investigate the safety, acceptability and efficacy and safety of the Alena CBT programme as a treatment for social anxiety disorder.
Detailed Description
This is a 6-week web-based parallel-group unblinded randomised controlled trial with a 4-week intervention period and a 2-week follow-up post intervention. Participants are randomly allocated to receive access to the Alena CBT programme or to a wait list control group, in a 1:1 ratio. The programme consists of CBT-based therapy for social anxiety based on the Clark and Wells model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety, Social Anxiety Disorder, Social Anxiety Disorder (Social Phobia)
Keywords
RCT, CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy program
Arm Type
Experimental
Arm Description
Access to the "Alena" CBT-based therapy programme for 4 weeks. Each of the four therapy modules gradually became available on a weekly basis until all four were available in the final intervention week. Participants were instructed to complete one module per week. Each therapy module consisted of psychoeducational content, guided psychological reflection and perspective-taking exercises, and, where appropriate, skills training exercises such as attention training, public speaking, and exposure experiments to be completed in real life.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Waitlist control. Participants in this arm were given access to the CBT content at the end of the 4-week trial period.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy programme
Intervention Description
This mobile application comprised CBT-based therapy for social anxiety based on the Clark and Wells model
Primary Outcome Measure Information:
Title
Questionnaires assessing negative effects from using the app and adverse health events
Description
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Time Frame
Week 4 (primary endpoint)
Title
Questionnaires assessing negative effects from using the app and adverse health events
Description
The Intervention group was asked "Have you experienced any negative effects from using the Alena app? This could be a physical or emotional effect that you believe you have experienced as a result of using the app and/or engaging in the app therapy." Both groups were asked: "Have you experienced any new, serious negative health effects in the past week? This includes having to see your GP for a new reason, going to hospital, or being otherwise very unwell in terms of your physical or mental health." If participants responded positively to either question, they were prompted for additional details and to rate the severity of the experience.
Time Frame
Week 6 (2-week follow-up post-intervention)
Title
Questionnaire assessing satisfaction, helpfulness and ease of use
Description
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Time Frame
Week 4 (primary endpoint)
Title
Questionnaire assessing satisfaction, helpfulness and ease of use
Description
Participants were asked how satisfied they were with the app overall (Likert rating scale from very dissatisfied to very satisfied); how helpful they found the app (Likert ratings from very unhelpful to very helpful); how likely they would be to recommend the app (Likert ratings from very unlikely to very likely); how easy they found using the app (Likert ratings from very difficult to very easy); whether they got to the end of the weekly exercise (yes/no), and what got in the way of completing the exercises, with options provided.
Time Frame
Week 6 (2-week follow-up post-intervention)
Secondary Outcome Measure Information:
Title
Social phobia inventory (SPIN)
Description
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.
Time Frame
Week 4 (primary endpoint)
Title
Social phobia inventory (SPIN)
Description
The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components. Total score ranging from 0 to 68, with higher scores indicating a worse outcome.
Time Frame
Week 6 (2-week follow-up post-intervention)
Title
Work and Social Adjustment Scale (WSAS)
Description
The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities. Total score ranging from 0 to 40, with higher scores indicating higher impairment
Time Frame
Week 4 (primary endpoint)
Title
Work and Social Adjustment Scale (WSAS)
Description
The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities. Total score ranging from 0 to 40, with higher scores indicating higher impairment
Time Frame
Week 6 (2-week follow-up post-intervention)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female
aged between 18 and 35 years old (inclusive)
located in the UK
fluent in English
comfortable taking part in a study that included deception (due to the nature of the cognitive assessments)
had an iPhone and daily access to an internet connection
scored over 30 on the Social Phobia Inventory (SPIN; indicating at least moderate social anxiety).
Exclusion Criteria:
currently undergoing any mental health therapy
changed the usual mental health medication or dosage within the past eight weeks
scored eight or above on the Alcohol Use Disorders Identification Test for consumption (AUDIT-C; indicating higher risk of alcohol dependence)
scored two or above on the adapted drug questions (indicating higher risk of drug dependence)
had previously participated in scientific studies or user research undertaken by Alena
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandana Ahmadi, PhD
Organizational Affiliation
Aya Technologies Limited
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aya Technologies Limited
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10827888
Citation
Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
Results Reference
background
PubMed Identifier
11983645
Citation
Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
Results Reference
background
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The Safety, Acceptability and Efficacy of Alena
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